Quality Manager

CURRICULUM-VITAE

NAGARJUNA REDDY.Y CONTACT ADDRESS:

SRT-261,

Phone: 098******** Sanath Nagar,

E-mail: skmsxg@r.postjobfree.com Hyderabad-500018.

OBJECTIVE:

Seeking a management position that will effectively utilize acquired expertise, creative talents and commitment to excellence. Desire a position with career growth potential.

EXPERIENCE: Total 4.2 years

1. Job Title : Microbiologist – Quality Control

Period of time : March 2009 to April 2010.

Organization : NESTLE, Riyadh-Saudi Arabia

2. Job Title : Microbiologist – Quality Control

Period of time : April 2006 to March 2009.

Organization : Aurobindo Pharma Ltd., Hyderabad.

AUDITS FACED :

• US-FDA, Australia-TGA, UK-MHRA, Customer and internal audits.

RESPONSIBILITIES:

• Ensuring that all the test procedures are followed. Reporting of all Raw Materials, finished products and water samples based on the test results.

• Handling of Validations and Protocols preparation.

• Preparation of monthly trend analysis reports, review & Implementation of GLP.

• Preparations of Monthly schedules and implementation with out deviations

• Review of documents and documentation as per regulatory guidelines.

• Handling of OOS, Incidents, Change Controls and deviations.

• Preparation and review of SOPs and GTPs and execution of Training activities.

• Analyst qualification.

• Sterile area and Equipment Qualifications.

• Performance verification, Maintenance of instruments and general laboratory apparatus in good condition.

VALIDATIONS:

• Water System Validation: Planning and Execution of Activity(Phase I, II, III, Flush time validation & Stagnant Study).

• Microbial Limit test Validations for Non sterile Products: Testing procedure validation challenging with known number of cells.

• Environmental Validations: Settle plate and Air sampling methods.

• Disinfectant Validation: Protocol preparation and implementation along with neutralizer validation for the disinfectants used in clean area.

• Media Hold Time Validation: Hold time validation for prepared media.

• Autoclave Validation: Autoclave validation using Biological indicators and Planning of Load patterns for validation study.

TESTS HANDLED:

• Microbial Limit Tests

• Monitoring of water quality by USP and EP Guidelines

• Personnel and environmental monitoring.

• Sterility testing of finished products

• Bacterial Endotoxin test (Gel Clot Method)

• Air sampling and swab analysis

• Cephalosporin contamination study in Non Cephalosporin blocks by micro methods.

• Preparation of Cell suspensions and maintenance of cultures for laboratory usage.

• ‘Particulate Matter testing’ in Injections by filtration method.

• Testing of Total Organic Carbon present in Water

• Drain Water Monitoring and UV efficacy testing .

• Compressed Gas and Nitrogen Gas testing.

EDUCATIONAL QUALIFICATION:

Post graduation: M. Sc. Microbiology (Specialization-Virology) with 72% from Sri Venkateswara University, Tirupathi (2004-2006).

Graduation : B. Sc. (Microbiology, Genetics, Chemistry) with 66.33% from Osmania University, Hyderabad (2001-2004).

Intermediate : Bi.P.C. (Biology, Physics, Chemistry) with 69.1% from Board of Intermediate Education, A.P. (1998-2000).

S.S.C. with 78.16% from Board of Secondary Education, A.P. (1997-1998).

STRENGTHS:

Team management, Flexible, through understanding of subject, and knowledge in cGMP& cGLP concepts.

ACHIEVEMENTS:

1. Investigation of Cephalosporin Contamination in Non Cephalosporin Products

2. Water System and Environmental Monitoring systems implimementations

PERSONAL PROFILE:

Name : Y. Nagarjuna Reddy

Father’s Name : Mr. Raghunatha Reddy

Date of Birth : 10-01-1983.

Marital Status : Single.

Languages known : English, Telugu, Hindi.

Permanent Address : Nambulapula Kunta,

Ananthapur-Andhrapradesh

I certify that to the best of my knowledge and belief the particulars given in the above are correct.

Yours sincerely,

NAGARJUNA REDDY. Y

Contact this candidate